Principal Investigator, Analytical
The incumbent will lead all analytical development for selected development compounds in our growing portfolio and serve as the analytical representative for cross-functional technical development teams which will include representatives from pre-formulation, formulation development, synthetic process development, manufacturing, regulatory CMC and quality assurance organizations. The incumbent will use state-of-the art techniques including HPLC/UPLC, LC-MS, vibrational spectroscopy, High-Field NMR, wet chemistry, thermal analysis (DSC, TGA), physical properties techniques (e.g. PXRD) and dissolution to generate and interpret data, solve complex problems, devise control strategies to ensure product and substance quality, and write relevant CMC sections of INDs and NDAs. Drug development activities will focus on early enabling first-in-human formulations through post approval changes to marketed products.
The incumbent will provide technical leadership in one or more aspects of analytical development and will actively coach technical staff in a variety of instrumental and wet chemical methods of analysis, experimental design, and/or statistical data analysis. The incumbent will be required to effectively interact with multiple functions across the organization, and effectively communicate results and strategies to staff and company executives. The incumbent will be skilled in the application of the cGMP and appropriately apply these between regulated and non-regulated activities.
With periodic supervision, the incumbent will be responsible for developing analytical test methods and control strategies facilitating phase appropriate drug substance and drug product development, manufacturing, and regulatory submissions supporting clinical study introduction through phase 3 trials and marketing applications. The incumbent will accomplish this through hands-on activity and/or supervision of staff, as well as partnering with 3rd parties. Activities include test method development and internal execution, method qualification/validation, site transfers and outside laboratory oversight. This incumbent will also support late stage troubleshooting and development of products, processes, and methods in support of product scale-up / commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited to:
- Develop and execute chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR, Release Rate, KF, LALS,) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials.
- Oversee 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results.
- Appropriately apply the cGMP between regulated and non-regulated activities.
- Collaboratively plan and execute cross functional studies for chemical development and formulation development.
- Independently, with occasional supervision, plan and execute in-house stability studies for drug substances, intermediates, and prototype drug products.
- Recognize and respond to unexpected or anomalous observations in all activities.
- Maintain complete and accurate records of laboratory work in conformance with company SOPs and training.
- Provide detailed reviews of internally generated data as well as that generated from contracted service providers.
- Travel, when necessary, to 3rd party manufacturing and/or testing sites.
A M.S./Ph.D. in a relevant scientific discipline (analytical chemistry preferred) and 8 + years of experience in the pharmaceutical industry. Principal Investigators must have strong fundamental knowledge of analytical chemistry, pharmaceutical analysis, hands-on experience with chromatography and other core analytical techniques, a good understanding of phase driven drug development, cGMP and familiar with guidance and policies from a variety of organizations (FDA, EMA, PMDA, ICH, etc.) and the overall CMC regulatory environment’s expectations for CMC.
Excellent communication skills are expected. Some prior supervisory and/or laboratory mentorship experience leading a small analytical team is an expectation.
Proficient using MS-Office, experienced with common data systems for computer controlled instrumentation (e.g. Waters, Agilent, Nicolet, TA).
Significant practical experience conducting HPLC analysis and troubleshooting.
Significant practical experience conducting method transfer both as the originating and receiving site
Significant experience evaluating analytical data and drawing meaningful conclusions
Strong attention to detail, excellent written and oral communication skills
Experience working in a timeline driven setting
Knowledge of cGMP expectations for laboratory records and quality systems
Ability to provide ideas for process improvements, and the enthusiasm to implement
Ability to work with a team of individuals to meet goals